Site Management Associate I

SmartRecruiters, Inc.; Bogotá ciudad; Híbrido; COP 42.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

SmartRecruiters, Inc. seeks a clinical research professional to support international projects in Bogotá on a hybrid basis. You will coordinate site communications, manage CTMS entries, and ensure regulatory submissions and training are up to date.

The role emphasizes document management, vendor liaison, site audits, and TMF maintenance with focus on accuracy and timely information flow across teams.

Only CVs in English accepted; prior CTA/CRO experience and a Life Sciences degree are preferred.

Formación

• College/University Degree in Life Sciences.
• Administrative work experience, preferably in international settings.
• Prior experience working as CTA for CROs.
• Prior experience in Clinical Research.
• Local regulations knowledge.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan and work in a dynamic team environment.
• Communication and collaboration skills.

Responsabilidades

• Be the main point of contact between site personnel and CRA involved in the project; assist with query resolution and EDC completion.
• Serve as the primary site contact for vendors, study supplies, and access management.
• Ensure pre-study testing (scans, qualification questionnaires, ECGs) at local site facilities is completed.
• Assist Monitors in CTMS data entry and track site issues and actions.
• Manage the order, receipt, inventory, distribution, return/recall and reconciliation of clinical supplies.
• Coordinate regulatory submissions and ethics committee notifications; stay updated on local rules.
• Prepare for and follow up on site, TMF and system audits/inspections.
• Maintain site and country TMF; file ISF and ISF checklists; distribute and update ISF.

Conocimientos

Administrative work experience

MS Office proficiency

Communication and collaboration

Team-oriented planning

Educación

Life Sciences degree

Herramientas

MS Office

Descripción del empleo

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

Only CVs in English will be accepted.

Hybrid opportunity in Bogotá.

You will be responsible for:

• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
• Serves as the primary sites’ contact point for vendors, study supplies, and access management.
• Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
• Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
• Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
• Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.
• Manage the TMF on a site and a country level for regularly and filedocuments. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
• Arrange and track initial and on-going project training for site teams in all vendor-related systems.
• Document Management and translations status review of the study.
• Ensures proper safety information flow with investigative sites.

Qualifications

• College/University Degree in Life Sciences;
• Administrative work experience, preferably in an international settings;
• Prior experience working as CTA for CROs;
• Prior experience working in Clinical Research;
• Local regulations knowledge;
• Full working proficiency in English;
• Proficiency in MS Office applications;
• Ability to planand work in a dynamic team environment;
• Communication and collaboration skills.

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new ideas while growing with the company.

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